Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number:... recall (Diagnostica Stago, Inc.)

Q: Is Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number:... (Diagnostica Stago, Inc.) recalled?

Yes. Diagnostica Stago, Inc. is recalling Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by . Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. The recall started February 5, 2026 and its status is ongoing. Recall number Z-1585-2026.

Medical deviceClass IIOngoing

Summary: Diagnostica Stago, Inc. is recalling Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by . Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

What is being recalled

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.

Why

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.

How to tell if yours is affected

Model/Catalog Number: REF 00515; UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515; Lot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall number	Z-1585-2026
Category	Medical device
Agency	U.S. Food and Drug Administration (FDA)
Severity	Class II
Status	Ongoing
Recall started	February 5, 2026
Reported	March 25, 2026
Company	Diagnostica Stago, Inc.
Company location	Parsippany, NJ, United States
Initiated by	Voluntary: Firm initiated
Quantity	34000 units (28446 US, 5554 OUS)

More recalls from Diagnostica Stago, Inc. · all medical device recalls · recalls from February 2026

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